Clinical Trial Coordinator

3 tygodni temu

Warszawa, Mazovia, Polska TN Poland Pełny etat

Transforming lives through clinical research is at the core of our mission at Thermo Fisher Scientific. As a leading global contract research organization, we are dedicated to improving health outcomes that people and communities depend on. Our purpose is to help customers deliver life-changing therapies, and our strategy is to bend the cost and time curve of drug development and optimize value for our customers.

Our team is expanding, and we are looking for a Clinical Trial Coordinator to join our client-dedicated team. In this role, you will provide technical support to the project team, coordinating non-clinical responsibilities of project administration as applicable to the client contract.

The ideal candidate will have a university degree or equivalent in education, training, and experience. You will be responsible for adhering to Good Clinical Practices, country-specific regulations, PPD/Client Standard Operating Procedures, and Working Practice Documents regulations for all non-clinical/clinical aspects of project implementation, execution, and closeout.

Key responsibilities will include:

  • Performing PPD investigator file reviews and logging outstanding issues in project-related tracking tools.
  • Reviewing regulatory documents for proper content.
  • Liasing with monitor and investigative sites to resolve outstanding regulatory issues identified.
  • Disseminating study-related information, including project tracking updates to clients, clinical study teams, and other PPD departments.
  • Assisting with the identification of potential investigators and development/distribution of initial protocol packets.

Additional responsibilities may include:

  • Coordinating, overseeing, and completing functions on assigned trials activities detailed on the task matrix.
  • Performing department, internal, country, and investigator file reviews as assigned and documenting findings in appropriate systems.
  • Ensuring allocated tasks are performed on time, within budget, and to a high-quality standard. Proactively communicating any risks to project leads.
  • Supporting the maintenance of study-specific documentation and systems, including but not limited to study team lists, tracking of project-specific training requirements, system access management, and tracking of project-level activity plans in appropriate systems.
  • Providing system support (GoBalto & eTMF).
  • Supporting RBM activities.
  • Performing administrative tasks on assigned trials, including timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
  • Supporting scheduling of client and/or internal meetings.
  • Reviewing and tracking local regulatory documents.
  • Transmitting documents to client and centralized IRB/IEC.
  • Analyzing and reconciling study metrics and findings reports. Assisting with clarification and resolution of findings related to site documentation.
  • Assisting with coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
  • Assisting with study-specific translation materials and translation QC upon request.

As a Clinical Trial Coordinator at PPD, part of Thermo Fisher Scientific, you will have the opportunity to work with a diverse group of professionals who share your passion for improving health outcomes. We value diverse experiences, backgrounds, and perspectives, and we encourage applicants from all walks of life to apply.

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